About this medicine
- Approved name
- Tysabri
- International non-proprietary name (INN) or common name
- natalizumab
- Associated names
- Tysabri
- Class
- -
About this procedure
- Current status
- European Commission final decision
- Reference number
- EMEA/H/A-20/1416/C/000603/0083
- Type
- Article 20 procedures
This type of procedure is triggered for medicines that have been authorised via the centralised procedure in case of quality, safety or efficacy issues.
- Authorisation model
- Centrally authorised product(s)
- Decision making model
- PRAC-CHMP-EC
Key dates and outcomes
- Procedure start date
- 07/05/2015
- PRAC recommendation date
- 11/02/2016
- CHMP opinion date
- 25/02/2016
- EC decision date
- 25/04/2016
- Outcome
- Risk minimisation measures